In a paper published in the Nov 20 issue of PLoS Collections, the researchers claim that CRTs today "pose distinct ethical challenges for several reasons," and "[a]lthough there is a small but growing literature on the subject, the ethical challenges raised by CRTs have yet to be systematically explored." In addition, interpreting existing ethics guidelines for CRTs "is complicated" because the trials are "uniquely designed."

"The lack of comprehensive guidance has resulted in uncertainty and markedly different interpretations as to permissible ethical practices in CRTs, both within and across countries," according to the paper

Led by the Ottawa Ethics of Cluster Randomized Trials Consensus Group, the team developed its recommendations after performing a 5-year mixed-methods research project. Funded by the Canadian Institutes of Health Research (CIHR), the study enabled the group to examine empirical studies that documented "ethical issues in published CRTs and interview "experienced trialists" and REC chairs.

In the PLoS paper, the researchers identify seven categories in which potential ethics concerns could be weeded out: justifying individual CRTs, REC reviews, identifying research participants, obtaining informed consent, defining the role of gatekeepers, assessing the benefits and harms of individual CRTs, and protecting "vulnerable" participants.

According to the paper, the 15 recommendations in general are meant to be ethical buoys to help design, conduct and review CRTs and to "ensure" that RECs review CRTs "robustly and appropriately." In particular, they are designed to "provide guidance on the need for REC review, the identification of research participants, obtaining informed consent, the role of gatekeepers in protecting group interests, the assessment of benefits and harms, the protection of vulnerable participants, and on the justification of a cluster randomized design."

According to the researchers, clusters can comprise medical practices, hospital wards, schools and communities that participate in CRTs. They stressed their recommendations are "primarily intended" for trial researchers and RECs and may "also be relevant" to research funders, policy makers, journal editors and potential study participants.

CROs

However, because of their in-depth approach the guidelines could also affect research organizations (CROs) — for instance, with additional trial costs — though the paper hasn't been in print long enough to determine precisely how. A spokesperson for the Association of Clinical Research Organizations (ACRO) said it "is currently reviewing the recommendations and has no position at this time."

To be sure, some CROs use internally devised checkpoints that closely reflect the Ottawateam's guidelines. Quintiles, the Durham, NC-based CRO, said it "already adheres to the ethical practices/guidelines outlined in the paper."

Dipti Amin, the company's chief compliance officer in the UK, added that ACRO-member CROs also adhere to principles provided by ACRO
and "are dedicated to ethical and lawful behavior in performing clinical research."

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